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510(k) Data Aggregation
(49 days)
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
The provided text describes the acceptance criteria and performance data for a Powder-Free Surgeon's Glove. The study is a standalone performance study to demonstrate that the device meets established standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 Requirement unless otherwise specified) | Reported Device Performance (SARI Value) | Pass/Fail |
|---|---|---|---|
| Length (5 ½ size) | 245 mm minimum | 270-272 mm | Pass |
| Length (6 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (6 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (7 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (7 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (8 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (8 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (9 size) | 265 mm minimum | 270-272 mm | Pass |
| Width (5 ½ size) | 70 +/- 6 mm | 68 mm | Pass (within range 64-76mm) |
| Width (6 size) | 76 +/- 6 mm | 73 mm | Pass (within range 70-82mm) |
| Width (6 ½ size) | 83 +/- 6 mm | 79 mm | Pass (within range 77-89mm) |
| Width (7 size) | 99 +/- 6 mm | 87 mm | Pass (within range 93-105mm) |
| Width (7 ½ size) | 95 +/- 6 mm | 92 mm | Pass (within range 89-101mm) |
| Width (8 size) | 105 +/- 6 mm | 103 mm | Pass (within range 99-111mm) |
| Width (8 ½ size) | 108 +/- 6 mm | 106 mm | Pass (within range 102-114mm) |
| Width (9 size) | 114 +/- 6 mm | 112 mm | Pass (within range 108-120mm) |
| Thickness (Cuff, Palm, Fingertip) | 0.1 mm minimum | 0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip) | Pass |
| Tensile Strength (Before Ageing) | 24 mpa | 27 mpa | Pass |
| Elongation at Break % (Before Ageing) | 750% | 850% | Pass |
| Modulus at 500% Elongation (Before Ageing) | 5.5 mpa (max) | 3 mpa | Pass |
| Tensile Strength (After Ageing) | 18 mpa min | 20 mpa | Pass |
| Elongation at Break % (After Ageing) | 560% min | 750% | Pass |
| Sterility | As per USP* | As per IP* | Pass (Implied by meeting IP standards) |
| Freedom from Holes | AQL 1.5 (S4 Level) | AQL 1.5 (S4 Level) | Pass (Stated to meet AQL) |
| Dimension | AQL 4 (S2 Level) | AQL 4 (S2 Level) | Pass (Stated to meet AQL) |
| Physical Property (Tensile strength, Elongation at break) | AQL 4 (S2 Level) | AQL 4 (S2 Level) | Pass (Stated to meet AQL) |
| Powder Content | Not specified in D3577 section, but stated to be 1 +/- 1 mg per glove | 1 +/- 1 mg per Glove | Pass |
| Protein Content | Not specified in D3577 section, but stated to be 80 +/- 20 ppm | 80 +/- 20 ppm | Pass |
| Moisture Content | Not specified in D3577 section, but stated to be 0.8% max | 0.8% max | Pass |
| Biocompatibility | Not specified in D3577 section, but stated to be Biologically Compatible | Biologically Compatible | Pass |
Note: IP (Indian Pharmacopea) and USP (United States Pharmacopeia) are both pharmacopoeial standards for sterility. Meeting IP, along with the claim of meeting or exceeding ASTM D3577, implies acceptable sterility.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "AQL followed" for various performance requirements, implying a sampling plan was used as per ASTM D3577, but the exact number of units sampled or tested is not provided.
- Data Provenance: The data is reported by "Sri.Anusham Rubber Industries Pvt. Ltd." which is located in Nagarcoil, Tamil Nadu, India. The data is retrospective in the sense that it's presented as the results of tests already conducted on their manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this study. The ground truth for device performance is established based on objective measurements against quantifiable standards (ASTM D3577) rather than expert consensus on interpretations of complex data like medical images.
4. Adjudication Method for the Test Set
This is not applicable as the determination of whether the device meets the criteria is based on objective, quantitative measurements against a predefined standard (ASTM D3577), not on subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers (e.g., radiologists interpreting images) and is not applicable to the performance testing of a physical medical device like a surgeon's glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document presents the intrinsic performance of the manufactured gloves against established standards (ASTM D3577 and other specific chemical/physical properties) without involving human operators in a comparative effectiveness setting. The "device" in this context is the glove itself, and its performance is assessed directly.
7. The Type of Ground Truth Used
The ground truth used is based on pre-defined, objective performance standards and specifications from ASTM D3577, as well as internal specifications for powder, protein, and moisture content, and biocompatibility. These are quantifiable criteria used to assess the physical, mechanical, and biological properties of the gloves.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or a software AI requiring a "training set" in the machine learning sense. The manufacturing process is designed to consistently produce gloves meeting these specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason mentioned in point 8.
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(45 days)
Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medi purpose, that is worn on the examiners hand or linger to prevent contamination between patie and Examiner.
Class I Patient Examination (Floves ( Nitrile) 801 7.A that meets all 'the requirements of ASTM D3578- 95.
Here's a breakdown of the acceptance criteria and study information for the Nitrile Examination Glove, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (Anusham Latex/SARI Value) |
|---|---|---|
| Length | ||
| EX-S | 220 mm minimum | 235-240 mm |
| S | 220 mm minimum | 235-240 mm |
| M | 230 mm minimum | 235-240 mm |
| L | 230 mm minimum | 235-240 mm |
| Width | ||
| EX S | 70 +/- 6 mm | 70MM |
| S | 80 +/- 6 mm | 82 mm |
| M | 95 +/- 6 mm | 93 mm |
| L | 111 +/- 6 mm | 107 mm |
| Thickness | ||
| EX S | 0.08 mm minimum | 0.10mm |
| S | 0.08 mm minimum | 0.10mm |
| M | 0.08 mm minimum | 0.10mm |
| L | 0.08 mm minimum | 0.10mm |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 14 mpa min | 18 - 20 mpa |
| Elongation at break % | 700% min | 750 - 800% |
| Physical Properties (After Ageing) | ||
| Tensile Strength | 14 mpa min | 16 - 18 mpa |
| Elongation at break % | 500% min | 650 - 700% |
| Performance Requirement: Freedom from Holes | AQL 4 (Level S4) | AQL 1.5 (Level S4) |
| Performance Requirement: Dimension | AQL 4 (Level S2) | AQL 4 (Level S2) |
| Performance Requirement: Physical Property | AQL 4 (Level S2) | AQL 4 (Level S2) |
| Powder Content | Not explicitly stated (implied by "AQL followed by SARI") | 120 +/- 20 mg per glove |
| Protein Content | Not explicitly stated (implied by "AQL followed by SARI") | 30 +/- 10 ppm |
| Moisture Content | Not explicitly stated (implied by "AQL followed by SARI") | 0.8% max |
| Biocompatibility | Not explicitly stated (implied by "AQL followed by SARI") | Biologically Compatible |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the exact sample size used for the performance testing. It refers to "Measured Parameters of Examination gloves (Nitrile) manufactured by Anusham Latex" and "Performance test data of the Nitrile examination glove manufactured by Sri. Anusham Rubber Industries Pvt Ltd".
- Data Provenance: The data is reported by M/s. SRLANUSHAM RUBBER INDUSTRIES PVT.LTD, located in TAMILNADU, INDIA. The data appears to be retrospective as it is presented as completed performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance data is based on physical and chemical testing against ASTM standards, not expert human assessment.
4. Adjudication method for the test set:
This is not applicable as the evaluations are based on objective physical/chemical measurements against predefined standards (ASTM D3578) rather than subjective expert interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This document describes the performance characteristics of a physical medical device (examination gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document describes the performance of a physical product.
7. The type of ground truth used:
The ground truth used for evaluating the device's performance is established industry standards and regulatory requirements, specifically:
- ASTM D3578-95: "Standard Specification for Rubber Examination Gloves." This standard defines the physical property requirements for examination gloves.
- FDA Pin Hole Requirement: A regulatory standard for barrier integrity.
- Labelling claim: The device's performance against its own stated specifications.
8. The sample size for the training set:
This information is not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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(45 days)
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
The provided text describes the acceptance criteria and performance data for a Nitrile Examination Glove (Powder free) manufactured by Sri.Anusham Rubber Industries Pvt. Ltd. This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study design for an AI/Software as a Medical Device (SaMD). Therefore, many of the requested details, such as those related to AI/MRMC studies, ground truth establishment, and sample sizes for training/test sets, are not applicable or available in this document.
However, I can extract the acceptance criteria and reported device performance from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Length (EX-S) | 220 mm minimum | 235-240 mm |
| Length (S) | 220 mm minimum | 235-240 mm |
| Length (M) | 230 mm minimum | 235-240 mm |
| Length (L) | 230 mm minimum | 235-240 mm |
| Width (EX S) | 70 +/- 6 mm | 70 mm |
| Width (S) | 80 +/- 6 mm | 82 mm |
| Width (M) | 95 +/- 6 mm | 93 mm |
| Width (L) | 111 +/- 6 mm | 107 mm |
| Thickness (all sizes) | 0.08 mm minimum | 0.10 mm |
| Tensile Strength (Before Ageing) | 14 mpa min | 18 - 20 mpa |
| Elongation at break % (Before Ageing) | 700% min | 750 - 800% |
| Tensile Strength (After Ageing) | 14 mpa min | 16 - 18 mpa |
| Elongation at break % (After Ageing) | 500% min | 650 - 700% |
| Freedom from Holes (AQL) | 4 | 1.5 |
| Dimension (AQL) | 4 | 4 |
| Physical Property (AQL) | 4 | 4 |
| Powder Content | 2 mg/glove max | Nil Powder (later reported as 1 +/- 1 mg per glove) |
| Protein Content | Value not fixed | "Value not fixed" (later reported as 30 +/- 10 ppm) |
| Moisture Content | Value not fixed | 0.8% max |
| Biocompatibility | Biologically Compatible | Biologically Compatible |
Summary of Device Performance against Acceptance Criteria:
The "Conclusion of Performance Test Data" section explicitly states that the Nitrile Examination gloves manufactured by Sri. Anusham Rubber Industries Pvt. Ltd.:
- "Meet or exceed the ASTM D3578"
- "Meet FDA Pin hole Requirement."
- "Meet labelling claim as shown by the data"
Based on the tables above, the reported device performance values generally meet or exceed the specified ASTM D3578 requirements. For example, length, thickness, tensile strength, and elongation are all within or above the minimum requirements. Width values are also largely within the +/- 6mm tolerance. The AQL for "Freedom from Holes" (1.5) is better (lower AQL indicates better quality) than the ASTM requirement (4). Powder content is reported as "Nil Powder" initially, and then "1 +/- 1 mg per glove", both of which are within the "2 mg/glove max" requirement. Protein content and moisture content, for which ASTM requirements were "Value not fixed," have reported values. Biocompatibility is also stated to be compatible with FDA requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size used for testing each characteristic. The "Level followed By SARI" for "Freedom from Holes," "Dimension," and "Physical Property" refers to inspection levels (S4, S2), which are part of a sampling plan (e.g., as per ISO 2859-1 or military standard 105E). These levels determine the severity of sampling, but not the absolute number of units tested.
- Data Provenance: The manufacturing company is M/s. SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD. in Tamil Nadu, India. The performance data is stated to be for gloves "manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD." This indicates the data is from tests performed on their products, likely at their facility or a contracted lab in India. The study is a prospective test of their manufactured products against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The "ground truth" here is defined by objective physical and chemical measurements governed by the ASTM D3578 standard, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As the "ground truth" is based on objective measurements against a standard, there is no expert adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance evaluation is based on objective measurements against an established international standard (ASTM D3578-95) for "Standard Specification for Rubber Examination Gloves." This standard defines acceptable physical properties, dimensions, and other characteristics.
8. The sample size for the training set
This section is not applicable. The document describes a physical product and its testing against a standard, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. See point 8.
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(164 days)
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.
Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.
The device being described is a Surgeon's Glove manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The acceptance criteria and performance data are primarily based on the ASTM D3577-91/95 specifications for latex surgeon's gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (ASTM D3577-95) | Reported Device Performance (SARI Value) | Result |
|---|---|---|---|
| Dimensions | |||
| Length (various sizes) | 245 mm minimum (size 5.5), 265 mm minimum (sizes 6-9) | 270-272mm (all sizes) | Meets |
| Width (various sizes) | Varies by size (e.g., 70 +/- 6 mm for 5.5, 114 +/- 6 mm for 9) | Consistent with ASTM ranges (e.g., 68mm for 5.5, 112mm for 9) | Meets |
| Thickness | 0.1mm minimum at cuff, palm, and finger | 0.12mm (cuff), 0.16mm (palm), 0.19mm (finger) | Meets |
| Physical Properties | |||
| Tensile Strength (Before Ageing) | 24 mpa min. | 31 mpa (SARI Value), 29 mpa (Performance Test Data) | Meets |
| Elongation at Break % (Before Ageing) | 750% min. | 950-975% (SARI Value), 850% (Performance Test Data) | Meets |
| Tensile Strength (After Ageing) | 18 mpa min. | 22 mpa | Meets |
| Elongation at Break % (After Ageing) | 560% min. | 850-900% (SARI Value), 800% (Performance Test Data) | Meets |
| Modulus at 500% Elongation (Before Ageing) | 5.5 mpa (max) | 3.4 mpa | Meets |
| Performance Requirements (AQL) | |||
| Freedom from Holes | AQL 1.5 | AQL 1.5 (SARI) | Meets |
| Dimensions | AQL 4 | AQL 4 (SARI) | Meets |
| Physical Property | AQL 4 | AQL 4 (SARI) | Meets |
| Other Properties | |||
| Powder Content | Not explicitly stated in ASTM, but implied compliance through SARI value. (ASTM D3577-95 typically specifies maximum powder residue) | 120 +/- 20 mg per glove (SARI Value for Powder Content) | Meets |
| Protein Content | FDA Requirement: Value not fixed | 80 +/- 20 ppm | Meets (no fixed requirement) |
| Moisture Content | FDA Requirement: Value not fixed | 0.8% (SARI Value/Maximum for Performance Test Data) | Meets (no fixed requirement) |
| Bio-compatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible | Meets |
| Sterility | NA (as per SARI) | "Fails Sterility" is a defect, not a performance metric for the device itself (AQL level "As per IP" for SARI, "As per USP" for ASTM is listed). The document doesn't explicitly state the glove is sterile, but rather that sterility failure is a defect. | N/A (implied that if claimed sterile it meets standard, but not explicitly stated as a performance criteria metric) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for tensile strength testing, number of gloves for hole testing). It refers to "SARI Value" and "Performance Test Data," suggesting internal testing by the manufacturer.
- Data Provenance: The data is retrospective, generated by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, a company located in Nagercoil, Tamil Nadu, S. India. It represents their internal testing results for the purposes of a 510(k) submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth is established by adherence to a recognized international standard, ASTM D3577-91/95, which defines the specifications for surgeon's gloves. The "Pioneer Manikandan Buildings" entity appears to be the manufacturer, not an expert panel for ground truth assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This type of study does not involve human expert adjudication in the traditional sense. The device's performance is objectively measured against a predefined technical standard (ASTM D3577).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This is a technical performance study for a physical medical device (surgeon's gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical product (surgeon's gloves), not an algorithm or software. Its performance is measured directly through physical and chemical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth is established by existing regulatory standards and technical specifications, specifically the ASTM D3577-91/95 for latex surgeon's gloves. This standard defines the required physical and chemical properties.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's evaluation, as it is not a machine learning model. The manufacturer would have internal quality control and manufacturing processes that produce gloves meeting the specifications, but this isn't a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (as per point 8). The manufacturing process and quality control would be geared towards consistent production of gloves that adhere to the ASTM D3577 standards.
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(73 days)
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
Class 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
The provided text outlines the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The study presented is a technical performance study demonstrating equivalence to a predicate device and adherence to ASTM and FDA standards for medical examination gloves.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578 / FDA Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Dimensions | ||
| Length (Ex-S to Ex-L) | 220 mm min (Ex-S, S); 230 mm min (M, L, Ex-L) | 240-245mm (Ex-S, S, M); 245-250mm (L, Ex-L) |
| Width (Ex-S to Ex-L) | 70 +/- 6 mm; 80 +/- 6 mm; 95 +/- 6 mm; 111 +/- 6 mm; 114 +/- 6 mm | 71mm (Ex-S); 82mm (S); 95mm (M); 106mm (L); 110mm (Ex-L) |
| Thickness (Ex-S to Ex-L) | 0.08 mm minimum | 0.11mm (Ex-S); 0.12mm (S, M); 0.10mm (L); 0.11mm (Ex-L) |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 14 mpa min. | 21-24 mpa |
| Elongation at Break % | 700% min. | 800-850% |
| Physical Properties (After Ageing) | ||
| Tensile Strength | 14 mpa min. | 19-22 mpa |
| Elongation at Break % | 500% min. | 700-800% |
| Performance Requirements (AQL) | ||
| Freedom from Holes | 4 (ASTM D3578) | 1.5 (SARI) |
| Dimensions | 4 (ASTM D3578) | 4 (SARI) |
| Physical Property | 4 (ASTM D3578) | 4 (SARI) |
| Other Properties | ||
| Powder Content | 2 mg/glove max (ASTM Requirement) | 1 +/- 1 mg per glove (also listed as 80 +/- 20, likely a typo or mislabeling in the document with the 1 +/- 1 mg per glove being the most direct statement of performance against 2mg/glove max) |
| Protein Content | Value not fixed (FDA Requirement) | 80 +/- 20 ppm |
| Moisture Content | Value not fixed (FDA Requirement) | 0.4% maximum |
| Biocompatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the performance tests. However, it indicates adherence to Acceptance Quality Limits (AQL) standards for inspection (S4 for holes, S2 for dimensions and physical properties), which implies a statistically determined sample size would have been used according to industrial quality control practices.
The data provenance is retrospective, as it's presented as part of a 510(k) submission, showcasing the device's characteristics against established standards. The data originates from India (SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, Tamil Nadu, India).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not applicable to this study. The "ground truth" for medical examination gloves is established by predefined international standards and regulations (e.g., ASTM D3578, FDA requirements) rather than expert consensus on individual cases. The testing involves objective measurements against these established criteria.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the "truth" is based on objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, where AI assistance might improve reader performance. This document concerns the physical and chemical properties of a medical glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in spirit, a standalone performance evaluation was done. The device (the glove) is evaluated on its own merits against specified criteria without human intervention affecting its inherent performance. The measurements taken for length, width, thickness, tensile strength, elongation, powder content, etc., are all objective assessments of the device itself.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-95: Standard Specification for Latex Examination Gloves.
- FDA Requirements: For general examination gloves, including pinhole requirements and biocompatibility.
8. The Sample Size for the Training Set
This concept is not applicable to the presented documentation. This is not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of traditional AI/ML. The manufacturing process of the gloves would involve quality control and process monitoring, but this doesn't constitute a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the manufacturing process would be the target specifications defined by ASTM D3578 and FDA regulations, guided by manufacturing best practices and quality control.
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